Contract advances Mirasol® System for the treatment of whole blood
LAKEWOOD, Colo.—October 21, 2013—Terumo BCT has been awarded a U.S. Department of Defense (DoD) cost-share contract worth up to $29.9M to advance the Mirasol System for the treatment of donated whole blood used in emergency transfusions in deployed military forces.
Terumo BCT is working with the U.S. Army Medical Research and Materiel Command to develop a U.S. Food and Drug Administration (FDA)-approved whole blood pathogen reduction device.
Under the terms of the contract, the DoD will fund $3.46M over the next three years (FY2013-FY2016) to complete the required tasks necessary to submit for FDA approval of the Mirasol system for whole blood.
The DoD has the option to equally share in the cost of additional safety and efficacy studies of pathogen-reduced whole blood and clinical trials as appropriate for a pre-market approval (PMA) application to FDA:
Under these options, the DoD would fund a maximum of $11.3M over the next four years.
Terumo BCT would cost share a maximum of $15.1M over the same period.
Cost sharing is the portion of a project cost not borne by the sponsor.
The new cost-share contract effort expands the Mirasol system development efforts initiated with the DoD in 2007.
The Mirasol system treats blood with a combination of riboflavin (vitamin B2), a non-toxic naturally occurring compound, and ultraviolet light to render a broad range of disease-causing viruses, such as West Nile virus and HIV, bacteria and parasites less pathogenic.
Raymond Goodrich, PhD, Terumo BCT, Vice President of Scientific and Clinical Affairs
"We are pleased to partner with the U.S. Army in advancing the development of the Mirasol system for whole blood, a critical resource developed to help improve the medical support capabilities for our soldiers in the field. With this collaboration, we aim to provide the best possible transfusion medicine option for war fighters and further Terumo BCT's mission to improve lives through innovation, quality and service."
"The Mirasol system for whole blood provides the potential for safe blood products in environments where this is not possible or practical today. Its use could change the way in which blood is made available to people on a global basis."
Major Charles DiTusa, Product Manager, U.S. Army Medical Materiel Development Activity (USAMMDA)
"Enhancing the safety of military blood products while retaining therapeutic efficacy is critical to the treatment of wounded service members on the battlefield, and is among the highest priorities of the Defense Medical Research and Development Program. Under this contract, Terumo BCT will perform critical studies toward FDA clearance of the Mirasol system for whole blood, a pathogen reduction device intended to decrease the risk of blood transfusion associated with bacteria, viruses, parasites and white blood cells."
Note: The Mirasol system is not FDA-approved for sale in the United States.
USAMMDA develops new drugs, vaccines and medical support equipment that enhance readiness, ensure the provision of the highest quality medical care to the DoD, and maximize survival of medical casualties on the battlefield.
About Terumo BCT:
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
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